MINIGUARD

External Urethral Occluder, Urinary Incontinence-control, Female

ADVANCED SURGICAL INTERVENTION, INC.

The following data is part of a premarket notification filed by Advanced Surgical Intervention, Inc. with the FDA for Miniguard.

Pre-market Notification Details

• Device ID: K954215
• 510k Number: K954215
• Device Name: MINIGUARD
• Classification: External Urethral Occluder, Urinary Incontinence-control, Female
• Applicant: ADVANCED SURGICAL INTERVENTION, INC. P.O BOX 3134 Dana Point, CA 92629
• Contact: Robert F Rosenbluth
• Correspondent: Robert F Rosenbluth; ADVANCED SURGICAL INTERVENTION, INC. P.O BOX 3134 Dana Point, CA 92629
• Product Code: MNG
• CFR Regulation Number: 876.5160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-09-08
• Decision Date: 1996-05-08
• Summary: summary